Impact of Acupuncture and Integrative Medicine on Patients Quality-of-life During National Emergency and Wartime
- Conditions
- Supportive Care
- Interventions
- Other: acupressure/relaxationOther: acupressure/relaxation with acupuncture
- Registration Number
- NCT06604455
- Lead Sponsor
- Carmel Medical Center
- Brief Summary
The current ongoing war in Israel, which began in October 2023 with a risk for spreading regionally across the Middle East, has presented a significant challenge to many patients, affecting also those receiving active oncology treatment. The present study examines a unique setting of care involving a diverse population of patients, including those receiving oncology treatment, from a widely diverse social, cultural and religious, background. Patients are offered integrative medicine treatments for 3 weeks with the goal of addressing war-related physical, emotional, and other quality of life-related concerns. After signing the informed consent form, patients will be randomly allocated to one of the two study interventions: acupressure-relaxation alone (Group A); or acupressure-relaxation modalities with acupuncture (Group B). The response to the study intervention for quality of life-related concerns will be re-assessed immediately; at 24-48 hours; and after 3 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) to determine the impact of the intervention on their QoL and concerns.
- Detailed Description
Integrative medicine is increasingly being included in supportive and palliative care, primarily in oncology settings. The current military conflict in Israel has led to a surge in cases of emotional and physical distress, overwhelming the health profession throughout the country.
Study objectives and purpose: The primary study objective is to improve patients\' QoL-related concerns including those affected by the military conflict.
Study design and setting: The study is taken place within a prospective randomized controlled methodology.
Study population: Patients of either gender, hospitalized for various indications (oncology or not) or undergoing out-patient oncology treatment, age ≥ 18 years.
Allocation to study arms and groups: Participants will be randomly assigned using the "Research Randomizer" online tool (https://www.randomizer.org/) to one of the following study groups:
* Single-modality integrative medicine, receiving acupressure/relaxation only (Group A)
* Multi-modality integrative medicine receiving acupressure/relaxation with acupuncture (Group B) In both study groups, the interviews will address quality of life-related concerns, including war-related concerns. Reassessment of these concerns will be conducted immediately post-treatment, 24-hour post treatment and following 3 weeks. patients in both groups will be offered weekly integrative medicine treatments during the 3 weeks following the first treatment .
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Patients diagnosed with cancer, age ≥ 18 years who are either hospitalized or undergoing oncology treatment in an outpatient care setting; or hospitalized for any other diagnosis
- Patients expressing quality of life related concerns affected directly or indirectly to the war and related security status.
Inability to read and provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Integrative medicine single-modality acupressure/relaxation Acupressure/relaxation only Integrative medicine multi-modality acupressure/relaxation with acupuncture Acupressure/relaxation with acupuncture
- Primary Outcome Measures
Name Time Method Assessing patients' quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW) Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment. In MYCAW, patients are asked to list and then score (from 0 to 6; 6 is most severe) their 2 most severe quality of life-related concerns
Assessment of objective physiological changes during the intervention During the 30 minutes integrative medicine intervention Assessment of objective physiological changes during the 30-minute integrative medicine intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout.
- Secondary Outcome Measures
Name Time Method Assessing patients' QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS) Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment. ESAS asks respondents to score a list of 10 QoL-related concerns on a scale from 0 (no symptom) to 10 (worst severity of the symptom).
Assessing patients' quality of life-related concerns using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Before and three weeks post-treatment. EORTC QLQ C-30 asks a number of quality of life-related clusters of concerns, from 1 (not at all) to 4 (very much).
Trial Locations
- Locations (1)
Carmel Medical center
🇮🇱Haifa, Israel